From the state of the art, for instance according to U.S. Pat. No. 6,849,078 B2, a tissue clip of this species is generally known as regards its basic design. For a better comprehension, this tissue clip is described hereinafter in detail with reference to FIG. 1.
Accordingly, such a clip 100 consists of a mouth-type clamping means having two toothed jaws 110, 120 adapted to be opened and shut via two lateral hinges 130 or by flexible moldings. The hinges 130 or the flexible moldings are preferably formed of spring-elastic straps which during opening the jaws 110, 120 store spring energy which results in a snapping of the jaws 110, 120 at a predetermined clamping force when the jaws 110, 120 are released, i.e. when the hinges 130 or the flexible moldings are actuated.
In detail, each clip 100 is punched in one piece out of a spring steel sheet by working a ring having a partially different ring width out of the spring steel sheet. Two diametrically opposed ring portions having a large ring width constitute the two jaws 110, 120, whereas the two ring portions disposed there between having a narrow ring width form the hinges 130 or the flexible moldings. The jaws 110, 120 are formed by arching the ring portions having a large ring width in a curved shape, wherein the two ring portions having a narrow ring width are twisted about their longitudinal axis by approximately 180° in order to form the hinges. This special shaping of the punched out spring steel sheet creates the shape of a type of shark mouth having two rows of teeth moving toward each other which are formed by punching out the ring portions having a large ring width.
The functioning of the afore-described medical tissue clip 100 can be described as follows:
In general, an endoscopic implantation of a medical device in total constitutes the most tolerable process for the patient. In this case the medical device must be fixed from the inside of a hollow organ to the latter. For this purpose, a number of the afore-described tissue cleats, clips or anchors are inserted into the hollow organ by means of an endoscope and are positioned at predetermined positions at the inner face of the organ. To this end, the respective clip or anchor is brought close to the organ tissue and the biasing spring is released for snapping of the clip or clamping of the anchor. The latter then clamps or holds a tissue fold between its jaws or its hooks or needles at a predetermined clamping or expanding force, wherein the teeth, hooks, needles or jags of each jaw cut into the tissue and preferably penetrate the same. In this way the clips or anchors are anchored to the inner face of the organ at predetermined spaces and thus form introducing points into the organ tissue for a tensile force.
The endoscope not shown in detail in FIG. 1 usually is equipped with an endoscope head or an endoscope cap which includes, apart from the functions generally required for an endoscope such as lighting, optical system and rinsing means, if necessary, in addition a holding and withdrawing means for the tissue clip. This holding and withdrawing means substantially consists of an expanding sleeve as well as a slide operable manually or by remote control which is movable in the longitudinal direction of the endoscope. The expanding sleeve is configured such that the already opened tissue clip can be attached to the sleeve in such manner that the clip can be prevented from slipping backwards while being inserted into the hollow organ. For this purpose, the slide is positioned axially behind the clip and serves so-to-speak as an axial stop for the clip.
As soon as the clip is to be positioned at a particular site, the slide is moved axially forward and in so doing strips off the clip over the expanding sleeve. Accordingly, the clip is actuated, i.e. the biasing mechanism within the clip described before by way of FIG. 1 is released when the latter is stripped off the expanding sleeve and the two jaws of the tissue clip snap to close while clamping the tissue provided there between.
Besides, for example the reference US 2008/0097182 A1 discloses a device for hemorrhage detection being adapted to ensure a continuous monitoring of bleeding within a hollow organ of a human patient which device uses a tissue clip according to the above description for fixing the device at the inner wall of the hollow organ. The known device will be described in the following text portion with reference to FIG. 9.
As may be gathered from FIG. 9, the device for hemorrhage detection is basically composed of an intracorporeal part and an extracorporeal part. Hereinafter, the intracorporeal part shall be described first. The intracorporeal part comprises a fixing member 202, which is a clip or anchor in this embodiment and which is mounted to an inner wall of the hollow organ, the digestive tract in this embodiment. A detecting means 203 is connected to the clip 202 via a connecting member 218, e.g. a cord or the like. In this embodiment, the detecting means 203 is composed of two light sources, one of which emits light in the UV range, and the other emits light in the red range of the visible spectrum, and a photosensitive sensor, such as a photodiode or a phototransistor. In a pulsed manner or successively, the light sources emit light into the interior of the hollow organ in which the light is absorbed and reflected, and the photosensitive sensor detects the light transmitted or reflected in the interior. The fixing means 202 can be formed as a stent-like structure or as a clip according to the above description. In this embodiment, the fixing means 202 is adapted to mount/fix the detecting means 203 in a tubular hollow organ, e.g. in the duodenum, for monitoring diffuse bleeding sources in the stomach or in the esophagus. The connecting member 218 for connecting the detecting means 203 to the fixing member 202 may be formed as a cord, a wire or the like. In an embodiment, the connecting member 218 is adapted to be made of a decomposing material, e.g. a biodegradable material, which decomposes gradually. Depending on the organ and the application, the decomposition time is set such that the connecting member 218 separates the fixing member 202 from the detecting means 203 only after, preferably directly after, a reasonable observation time has elapsed. This measure permits the detecting means 203 to be excreted naturally through the digestive tract, separately from the fixing member 202. The detecting means 203 is connected to a transmitting unit 217 by means of a data transmitting cable, so that signals are transmissible between the photosensitive sensor and the transmitting unit 217. Alternatively, the detecting means may be anchored in the transmitting unit 217 or may be unitarily formed therewith. The transmitting unit 217 is basically composed of a data processing unit 204, an analog-digital converter 205, an energy source 206, e.g. a battery, and a transmitter 207. The data processing unit 204 controls the detecting means 203, the analog-digital converter 205 and the transmitter 207, and evaluates the data received by the photosensitive sensor. The analog-digital converter 205 converts the analog signals sent by the detecting means 203 into digital signals, and the transmitter 207 forwards the data evaluated by the data processing unit 204 to a receiving unit 209. The data transmitted by the transmitter 207 may be e.g. measured values, status information or event signals, e.g. the event of the occurrence of a bleeding. In this embodiment, the transmitting unit 217 is surrounded by an encapsulation 208, in order to protect the elements of the transmitting unit 217. In one example, the encapsulation is formed of a body-compatible material. The extracorporeal part is basically composed of a receiving unit 209, an interface 210, and an evaluation unit 211. The receiving unit 209 receives data sent by the transmitter 207 via a wireless transmission. The data received by the receiving unit in this way are adapted to be evaluated or represented in an evaluating unit 211 may e.g. be an optical device or an acoustic signaling device, such as a display or a loudspeaker. Furthermore, the data received by the receiving unit are transmissible by means of the interface 210 to third parties, e.g. a doctor or an emergency hotline/center. Hereinafter, the function of the device for hemorrhage detection shall now be described. The intracorporeal part composed of anchor 202, detecting means 203 and transmitting unit 217 is introduced into the digestive tract by means of an endoscope. There, the anchor 202 is fixed to an inner wall of the digestive tract by means of the endoscope. Thus, the detecting means 203 and the transmitting unit 217 are fixed in the interior of the digestive tract by the anchor 202. There, the detecting means 203 detects whether there is any blood in the digestive tract, or not. This works as follows: the two light sources of the detecting means 203, which emit light at a predetermined wavelength, are controlled by the receiving unit 204 such that each light source emits light successively, the one light source emits light in the UV range, and the other light source emits light in the red range of the visible spectrum. The light emitted by the light sources emerges into the interior of the digestive tract, and is absorbed or reflected by the contents in the interior. The photosensitive sensor in the form of a photodiode or phototransistor, formed in the detecting means 203, detects the light transmitted or reflected in the interior of the digestive tract, and produces a sensor signal on the basis of the detected light. Thus, one sensor signal is generated for each light source. If there is any blood in the interior of the digestive tract, the light emitted by the light sources in absorbed differently, as if there is no blood in the digestive tract, since blood has a specific characteristic absorption spectrum that differs from the absorption spectrum of the “normal” organ contents. Accordingly, the light reflected in the interior and received by the photosensitive sensor dependence on the presence of blood in the interior of the organ and, accordingly, also the sensor signals that are sent out by the photosensitive sensor are different depending on the presence or absence of blood. Thus, due to the different sensor signals of the photosensitive sensor, the presence or absence of blood may be detected.
In practice, it turned out, that especially the insertion action of a capsule-like device of this kind into the hollow organ using an endoscopic instrument creates problems in so far as, on the one hand, the capsule-like device has to be held inside the endoscopic instrument such it will not unintentionally be stripped off when being inserted into the hollow organ. On the other hand, however, for a smooth positioning action at the inner wall of the hollow organ the capsule-like device has to be disconnected from the endoscopic device in a simple manner wherein the function of the above-mentioned clip and of the endoscopic device itself should not be affected.
For example, the WO 2011/066431 discloses a wireless capsule-like device being endoscopically anchored to the bowel wall using an endoscopic clip. In this implementation, the capsule-like device is designed to be integral part of the endoscopic clip with a minimum dimension on the 3 mm-scale in order to be introduced through the working channel of an endoscope into the hollow organ of the body.
A technical drawback of this solution is that the form factor is not compatible with currently commercially available battery technology, as the smallest button cell available has an outer diameter of 4.8 mm (e.g. Type 337 battery sold under the trademark Energizer®). Furthermore, it is known that for telemetric data transmission the antenna configuration inside the capsule-like device benefits from being surrounded by isolating material such as a plastic mold creating a distance to electrolytes such as biological tissue. In other words, an implementation of the capsule-like device in which the antenna is physically close to biological tissue surrounding the capsule-like device leads to significant damping effects on the electromagnetic waves being emitted from the antenna. Thus, for an appropriate signal strength outside the body, high output power may be necessary, which on the other hand may lead to undesired effects on the surrounding tissue.
For this reason, capsule-like wireless devices for monitoring of parameters such as the detection of bleeding, an embodiment with minimum outer dimensions in the range of at least 5 mm is technologically advantageous. However, the implantation through the working channel of an endoscope, which is usually in the 3 mm range, is not possible. On the other hand, with endoscopic delivery devices such as the delivery device sold by US Endoscopy, Ohio, USA under the trademark AdvanCE®, it is possible to deliver capsule-like devices with outer diameter in the range of at least 5 mm into a hollow organ of the body. These type of devices, however, do not have the capability of anchoring the capsule-like device to the wall of the hollow organ.
An integral endoscopic implanting apparatus which offers both the possibility of safe and easy introduction as well as secure anchoring of the capsule-like device of this kind is not known at present.
For this reason, it is desirable to provide an implanting apparatus or instrument for at least temporarily implanting a capsule-like device using a clip as a fixing means, wherein said implanting apparatus or instrument allows a safe insertion of the capsule-like device into a hollow organ of, for example, a human patient and a smooth disconnection of the capsule-like device when the clip gets fixed at the hollow organ.